The big news in the IEC 60601-1, 3rd ed. world today is the US National Standard that is in the FDA’s Recognized Consensus Standards Lists [Now is ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) – Recognition List #:
South Korea MFDS Amends it’s Medical Devices Act & Will Require IEC 60601-1, 3rd ed + Amendments
There were three major changes to South Korea’s Medical Devices Act and the Enforcement of the Medical Devices Act as of 8 May 2013.
IEC 60601-1, 3rd ed. related standards changes & new Interpretation Sheet 3
IEC 60601-1, 3rd ed. has been out for about 7 years now and there have been lots of changes within the IEC 60601 series of standards to align with 3rd edition.
Presentation on Navigating FDA’s Home Use Medical Devices Draft Guidance
Leo Eisner will be presenting on the topic “Navigating FDA’s Draft Guidance on Home Use Medical Devices” at an FX Conferences event on 11 July, 2013 (Thurs) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern). You don’t have to
Reminder Presentation on IEC60601-1, 3rd edition, Amendment 1 & its Impact on Users on 2 May ’13
Leo Eisner will be speaking on “IEC 60601–1, 3rd Edition, Amendment 1 and its Impact on Users” at an FX Conferences event on May 2, 2013 (Thurs) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern). You don’t have to